This Article studied the actual effect of the United States Supreme Court's decision in Ashcroft v. Iqbal on the cohort of more than 264 federal pharmaceutical and medical device cases of every type, released from the day of the decision in Iqbal through August 31, 2010. The results of this...

New medical technologies are a leading driver of U.S. health care spending. This report identifies promising policy options to change which medical technologies are created, with two related policy goals: (1) Reduce total health care spending with the smallest possible loss of health benefits,...

While Australia has enjoyed the benefits of a National Medicines Policy (NMP) for many years, there is no national equivalent policy for medical devices. This is despite an established medical device legal framework that spans multiple departments across the Australian Government. The existing...

The Covid-19 pandemic tragically emphasized severe failures of health systems. In particular, the saturation of hospital infrastructures and the lack of medical devices is crucial for respiratory ventilators. The medical and pharmaceutical sectors had to find urgently new ways to innovate...

Microbiology is the study of microorganisms such as bacteria, protozoa, fungi and similar organisms that can't be seen with the naked eye. The need to study these minute organisms started when scientists discovered the association of microbes to specific diseases. The roles of microbiology on...

What is computer systems validation (CSV)? -- CGMP regulatory requirements for production computer systems -- Maxims in CSV -- General CSV principles -- System lifecycle (SLC) -- SLC documentation (cover the data integrity in documentation) -- Management of the computer system requirements --...